Omeprazole (Lexi-Drugs)

Pronunciation

(oh MEP ra zole)

Brand Names: US

PriLOSEC; PriLOSEC OTC [OTC]

Brand Names: Canada

APO-Omeprazole; Auro-Omeprazole [DSC]; BIO-Omeprazole; DOM-Omeprazole DR [DSC]; JAMP-Omeprazole DR; Losec; MYLAN-Omeprazole [DSC]; NAT-Omeprazole DR; Omeprazole-20; PMS-Omeprazole; PMS-Omeprazole DR; Priva-Omeprazole; Q-Omeprazole [DSC]; RAN-Omeprazole; RATIO-Omeprazole [DSC]; RIVA-Omeprazole DR; SANDOZ Omeprazole; SANDOZ Omperazole; TEVA-Omeprazole; VAN-Omeprazole

Dosing: Adult

Duodenal ulcer: Oral: 20 mg once daily for 4 weeks; some patients may require an additional 4 weeks. Up to 40 mg once daily has been used in patients with ulcers refractive to other therapies (eg, H2 antagonists) (Bardhan 1991).

Dyspepsia (off-label use): Oral: 20 mg once daily for up to 4 weeks (Meineche-Schmidt 2004; Pinto-Sanchez 2017; Veldhuyzen van Zanten 2005).

Gastric ulcers: Oral: 40 mg once daily for 4 to 8 weeks; in clinical trials, healing rates of ulcers ≤1 cm at 4 and 8 weeks were similar between omeprazole 20 mg and 40 mg; for ulcers >1 cm omeprazole 40 mg was significantly more effective at 8 weeks.

Gastroesophageal reflux disease (GERD), treatment: Note: Administer 30 to 60 minutes before a meal (breakfast is preferred). Lifestyle and dietary modifications are also recommended (ACG [Katz 2013]).

Initial therapy:

Mild and intermittent symptoms (<2 episodes/week), and no evidence of erosive esophagitis: Note: Some experts consider PPI use in these patients only if symptoms persist following standard-doses of histamine 2 receptor antagonists (Kahrilas 2019). Oral: 20 mg once daily for 8 weeks; if symptoms persist after 8 weeks, increase to 40 mg once daily; once symptoms are controlled, continue treatment for at least 8 weeks. Discontinue therapy when asymptomatic for 8 weeks with therapy (consider tapering before discontinuing) (Kahrilas 2019).

Severe or frequent symptoms (≥2 episodes/week), erosive esophagitis or Barrett esophagus: Oral: 40 mg once daily; once symptoms are controlled, continue treatment for at least 8 weeks. In patients with severe erosive esophagitis or Barrett esophagus, long-term maintenance therapy with 40 mg once daily is warranted. In patients without severe erosive esophagitis or Barrett esophagus, continue at the lowest dose for the shortest duration appropriate, discontinue therapy in all asymptomatic patients (consider tapering before discontinuing) (Kahrilas 2019; Ramakrishnan 2002) Note: In Asian patients, consider using 10 mg once daily for the maintenance healing of erosive esophagitis due to increased bioavailability (manufacturer’s labeling).

Refractory:

Persistent symptoms despite 40 mg once daily dosing regimen: Note: Referral to a specialist is recommended: Oral: 40 mg twice daily (before breakfast and dinner) (Fass 2019; Hershcovici 2010; ACG [Katz 2013]) or some experts consider splitting the 40 mg once daily dose and administering 20 mg twice daily before breakfast and dinner (Fass 2019).

Recurrent symptoms after discontinuing acid suppression:

Recurrent symptoms ≥3 months: Repeat an 8-week course at the previously effective dose (Kahrilas 2019).

Recurrent symptoms <3 months: Long-term maintenance at the lowest effective dose necessary; upper endoscopy is also recommended (if not already performed) (ACG [Katz 2013]; Kahrilas 2019).

OTC labeling (patient-guided therapy): Heartburn, frequent symptoms (≥2 episodes/week): 20 mg once daily for 14 days (maximum: 20 mg/day); may repeat a 14-day course every 4 months, if needed.

Helicobacter pylori eradication: Oral: Dose varies with regimen:

Manufacturer labeling:

Dual therapy: 40 mg once daily administered with clarithromycin 500 mg 3 times daily for 14 days. In patients with presence of ulcer at time of therapy initiation, continue omeprazole 20 mg once daily for an additional 14 days after completion of dual therapy.

Triple therapy: 20 mg twice daily administered with amoxicillin 1,000 mg and clarithromycin 500 mg twice daily for 10 days. In patients with presence of ulcer at time of therapy initiation, continue omeprazole 20 mg once daily for an additional 18 days after completion of triple therapy.

American College of Gastroenterology guidelines (Chey 2007; Chey 2017):

Clarithromycin triple regimen: 20 to 40 mg twice daily in combination with clarithromycin 500 mg twice daily and either amoxicillin 1 g twice daily or metronidazole 500 mg 3 times daily; continue regimen for 14 days. Note: Avoid use of clarithromycin triple therapy in patients with risk factors for macrolide resistance (eg, prior macrolide exposure, local clarithromycin resistance rates ≥15%, eradication rates with clarithromycin-based regimens ≤85%) (ACG [Chey 2017]; Fallone 2016).

Bismuth quadruple regimen: 20 mg twice daily in combination with tetracycline 500 mg 4 times daily, metronidazole 250 mg 4 times daily or 500 mg 3 or 4 times daily, and either bismuth subcitrate 120 to 300 mg 4 times daily or bismuth subsalicylate 300 mg 4 times daily; continue regimen for 10 to 14 days.

Concomitant regimen: 20 mg twice daily in combination with amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and either metronidazole or tinidazole 500 mg twice daily; continue regimen for 10 to 14 days.

Sequential regimen: 20 mg twice daily plus amoxicillin 1 g twice daily for 5 to 7 days; then continue omeprazole along with clarithromycin 500 mg twice daily, and either metronidazole or tinidazole 500 mg twice daily for 5 to 7 days.

Hybrid regimen: 20 mg twice daily plus amoxicillin 1 g twice daily for 7 days; then continue omeprazole and amoxicillin along with clarithromycin 500 mg twice daily, and either metronidazole or tinidazole 500 mg twice daily for 7 days.

Levofloxacin triple regimen: 20 mg twice daily in combination with amoxicillin 1 g twice daily and levofloxacin 500 mg once daily; continue regimen for 10 to 14 days.

NSAID-induced ulcer prophylaxis (off-label use): Oral: 20 mg once daily for up to 6 months (Cullen 1998; Lanza 2009; Regula 2006).

NSAID-induced ulcer treatment (off-label use): Oral: Initial: 20 mg once daily for 4 to 8 weeks; Maintenance: 20 mg once daily for up to 6 months (Bianchi 1998; Hawkey 1998; Yeomans 1998).

Pathological hypersecretory conditions: Oral: Initial: 60 mg once daily; doses up to 120 mg 3 times daily have been administered; administer daily doses >80 mg in divided doses. Treat as long as clinically indicated; some patients have been treated continuously for >5 years.

Stress ulcer prophylaxis in critically ill patients (off-label use): Oral or via NG tube: 40 mg once daily (Levy 1997) or may administer 40 mg loading dose followed by 20 to 40 mg once daily (ASHP 1999). Note: Intended for patients with associated risk factors (eg, coagulopathy, mechanical ventilation for >48 hours, sepsis/septic shock); discontinue use once risk factors have resolved (Rhodes 2017). Omeprazole 20 mg via NG tube once daily may be less effective in some critically-ill populations compared to 40 mg via NG tube once daily (Balaban 1997).

Discontinuation of therapy: Oral: Some experts recommend a step-down approach in order to avoid worsening or rebound symptoms. One strategy is to decrease the dose by 50% over 2 to 4 weeks. If the patient is already on the lowest possible dose, alternate-day therapy may be considered. If symptoms worsen during treatment or after discontinuation, patient should be re-evaluated (Kim 2018).

Dosing: Geriatric

Refer to adult dosing. Bioavailability may be increased in elderly patients.

Dosing: Renal Impairment: Adult

No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

Mild to severe impairment (Child-Pugh class A, B, or C): 10 mg once daily when used for maintenance of healing of erosive esophagitis. There are no dosage adjustments provided for the other indications. Alternatively, a maximum dose of 20 mg/day regardless of indication, has been recommended (Losec Canadian product labeling). In a very small study, omeprazole systemic exposure and half-life increased ~2- and ~3-fold respectively, in patients with mild to severe hepatic impairment.

Dosing: Pediatric

Erosive esophagitis, treatment (short-term): Oral: Infants, Children, and Adolescents: Note: Duration of therapy for infants is up to 6 weeks. The duration of therapy for children and adolescents is 4 to 8 weeks; may continue for an additional 4 weeks if no response to 8 weeks of treatment; with recurrence of erosive esophagitis or GERD symptoms (eg, heartburn), an additional 4 to 8 week course may be considered

3 to <5 kg: 2.5 mg once daily

5 kg to <10 kg: 5 mg once daily

10 kg to <20 kg: 10 mg once daily

≥20 kg: 20 mg once daily

Erosive esophagitis, maintenance of healing: Children and Adolescents: Oral:

5 kg to <10 kg: 5 mg once daily

10 kg to <20 kg: 10 mg once daily

≥20 kg: 20 mg once daily

GERD: Oral:

Fixed dosing: Children and Adolescents:

5 kg to <10 kg: 5 mg once daily

10 kg to <20 kg: 10 mg once daily

≥20 kg: 20 mg once daily

Weight-directed dosing: Infants, Children, and Adolescents: 0.7 to 3.3 mg/kg/day (AAP [Lightdale 2013]); maximum daily dose: 20 mg/day; the dose most frequently reported to provide healing of esophagitis and relief of GERD symptoms is 1 mg/kg/day (Zimmerman 2001)

Helicobacter pylori eradication: Oral: Children and Adolescents: Note: Usual duration of therapy is 7 to 14 days; use in combination with antimicrobials (eg, clarithromycin, metronidazole, amoxicillin).

Weight-based: 1 to 2 mg/kg/day divided into 2 doses; maximum dose: 20 mg/dose (Gold 2000; NASPGHAN/ESPGHAN [Koletzko 2011])

Fixed dosing (Gottrand 2001):

15 to 30 kg: 10 mg twice daily

>30 kg: 20 mg twice daily

Dosing: Renal Impairment: Pediatric

Infants, Children, and Adolescents: No dosage adjustments are recommended

Dosing: Hepatic Impairment: Pediatric

Infants, Children, and Adolescents: There are no dosage adjustments provided in the manufacturer’s labeling. However, based on increased bioavailability, dosage adjustment should be considered, especially for maintenance healing of erosive esophagitis. Specific guidelines are not available.

Use: Labeled Indications

Duodenal ulcer (Rx only): Short-term treatment (4 to 8 weeks) of active duodenal ulcer in adults.

Gastric ulcer (Rx only): Short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults

Gastroesophageal reflux disease (Rx only):

Treatment of erosive esophagitis: Short-term treatment (4 to 8 weeks) of erosive esophagitis (EE) due to acid-mediated gastroesophageal reflux disease (GERD) diagnosed by endoscopy in patients ≥1 year; short-term treatment (up to 6 weeks) of EE due to acid-mediated GERD in pediatric patients 1 month to <1 year.

Maintenance healing of erosive esophagitis: Maintenance healing of EE due to acid-mediated GERD in patients ≥1 year.

Symptomatic gastroesophageal reflux disease: Treatment of heartburn and other symptoms associated with GERD for up to 4 weeks in patients ≥1 year.

Heartburn (OTC only): Treatment of frequent, uncomplicated heartburn (occurring ≥2 or more days per week) in adults.

Helicobacter pylori eradication (Rx only):

Dual therapy: Treatment of H. pylori infection and duodenal ulcer disease (active or up to 1-year history) in combination with clarithromycin to eradicate H. pylori in adults.

Triple therapy: Treatment of H. pylori infection and duodenal ulcer disease (active or up to 1-year history) in combination with clarithromycin and amoxicillin to eradicate H. pylori in adults.

Pathological hypersecretory conditions (Rx only): Long-term treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome, multiple endocrine adenomas, systemic mastocytosis) in adults.

Use: Off-Label: Adult

  DyspepsiaLevel of Evidence [A, G]

Data from two randomized, double-blinded, placebo-controlled parallel design trials support the use of omeprazole for the treatment of dyspepsia Ref. In addition, data from a systematic review support the use of omeprazole for the treatment of patients with ulcer and reflux-like functional dyspepsia Ref.

Based on the American College of Gastroenterology (ACG) and Canadian Association of Gastroenterology (CAG) guidelines for the management of dyspepsia, the use of omeprazole is effective and recommended treatment for dyspepsia and functional dyspepsia in patients <60 years of age who are H. pylori negative or who remain symptomatic after H. pylori eradication therapy Ref.

  NSAID-induced ulcer prophylaxisLevel of Evidence [B, G]

According to the American College of Gastroenterology 2009 Guidelines for Prevention of NSAID-Related Ulcer Complications, proton pump inhibitors are effective and recommended in the prophylaxis of gastric and duodenal ulcers in patients receiving NSAID therapy Ref.

Data from randomized, double-blind, parallel-group studies support the use of omeprazole in the prevention of NSAID-induced gastric and duodenal ulcers Ref.

  NSAID-induced ulcer treatmentLevel of Evidence [B]

Data from a randomized, single-blinded study and randomized, double-blind studies support the use of omeprazole as treatment for NSAID-induced gastric and duodenal ulcers Ref.

  Stress ulcer prophylaxis in critically ill patientsLevel of Evidence [B, G]

Data from a prospective randomized clinical trial in patients at high risk for stress ulcer prophylaxis administered either omeprazole or IV ranitidine, support the use of omeprazole for the prevention of stress ulcers Ref. Additional trials may be necessary to further define the role of omeprazole in this setting.

Based on the Surviving Sepsis Campaign International Guidelines for the Management of Severe Sepsis and Septic Shock, stress ulcer prophylaxis using a proton pump inhibitor or a histamine H2-receptor antagonist is recommended in sepsis or septic shock patients who have GI bleeding risk factors.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Barrett Esophagus:

ACG, “Diagnosis and Management of Barrett’s Esophagus,” January 2016

Critical Care:

“Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016,” March 2017

Drug-Induced Liver Injury:

American College of Gastroenterology (ACG), “2014 ACG Guideline for Idiosyncratic Drug-induced Liver Injury,” July 2014

Dyspepsia:

ACG/CAG “Guidelines for the Management of Dyspepsia,” June 2017

Gastroesophageal Reflux Disease:

ACG, “Guidelines for the Diagnosis and Management of Gastroesophageal Reflux Disease,” March 2013

AGA, “Medical Position Statement on the Management of Gastroesophageal Reflux Disease,” October 2008

Helicobacter pylori Infection:

“ACG Guideline on the Treatment of Helicobacter pylori Infection,” February 2017

“ACG Guideline on the Management of Helicobacter pylori Infection,” August 2007

NSAID-Related Ulcers:

“ACG Guidelines for Prevention of NSAID-Related Ulcer Complications,” February 2009

Proton Pump Inhibitors & Thienopyridines:

ACCF/ACG/AHA, “2010 Expert Consensus Document on the Concomitant Use of Proton Pump Inhibitors and Thienopyridines,” December 2010

ACCF/AHA/SCAI, “2011 Guideline for Percutaneous Coronary Intervention,” November 2011

“The Use of Antiplatelet Therapy in the Outpatient Setting: Canadian Cardiovascular Society Guidelines,” 2011

Administration: Oral

Administer 30 to 60 minutes before a meal; best if taken before breakfast (ACG [Katz 2013]). If administering twice daily, first dose should be administered before breakfast and the second dose before dinner (ACG [Katz 2013]; Hershcovici 2010).

Capsule: Swallow whole; do not chew or crush. Capsule may be opened and contents mixed with 1 tablespoon of applesauce (soft enough to swallow without chewing). Swallow immediately with a glass of cool water; mixture should not be chewed, crushed, warmed, or saved for future use.

Oral suspension: Following reconstitution, the suspension should be left to thicken for 2 to 3 minutes and administered within 30 minutes. If any material remains after administration, add more water, stir, and administer immediately.

Tablet: Swallow whole with a glass of water before morning meal; do not crush or chew.

Administration: Other

Nasogastric/Gastric tube: Administer 30 to 60 minutes before meals; may take with antacids. If administering twice daily, first dose should be administered before breakfast and the second dose before dinner (ACG [Katz 2013]; Hershcovici 2010).

Oral suspension (using packets): Add 5 mL of water to catheter tipped syringe and then add contents of a 2.5 mg packet (or 15 mL of water for the 10 mg packet). Immediately shake syringe and leave to thicken for 2 to 3 minutes; shake syringe again and within 30 minutes administer via NG or gastric tube (French size 6 or larger). Refill syringe with an equal amount of water, shake, and flush remaining contents through NG or gastric tube

Oral suspension (using capsules): The manufacturer of Prilosec does not give recommendations for extemporaneous preparation of omeprazole capsules for NG/OG administration. Consider using the packets for oral suspension. If packets are unavailable, methods of preparation of capsules for NG/OG administration have been described (Balaban 1997; Phillips 1996). An extemporaneously prepared suspension with extended stability may also be used (DiGiacinto 2000; Quercia 1997; Sharma 1999).

Administration: Pediatric

Oral: Should be taken before meals; best if taken 30 minutes before a meal (AAP [Lightdale 2013]); may be administered with antacids.

Capsule: Should be swallowed whole; do not chew or crush. Delayed release capsule may be opened and contents added to 1 tablespoon of applesauce; use immediately after adding to applesauce; do not chew. Follow with a cool glass of water. Applesauce should not be heated.

Oral suspension: Empty the contents of the 2.5 mg packet or 10 mg packet into 5 mL or 15 mL of water, respectively; stir, the suspension should be left to thicken for 2 to 3 minutes and administered within 30 minutes. If any material remains after administration, add more water, stir, and administer immediately.

Tablet: Should be swallowed whole; do not crush or chew.

Nasogastric tube administration:

Capsule: The manufacturer of Prilosec does not give recommendations for extemporaneous preparation of omeprazole capsules for NG/OG administration. Consider using the packets for oral suspension. If packets are unavailable, methods of preparation of capsules for NG/OG administration have been described (Balaban 1997; Phillips 1996). An extemporaneously prepared suspension with extended stability may also be used (DiGiacinto 2000; Quercia 1997; Sharma 1999).

Oral suspension: Add 5 mL of water to a catheter-tipped syringe and then add the contents of a 2.5 mg packet (or 15 mL of water for the 10 mg packet), shake the suspension well and leave to thicken for 2 to 3 minutes. Administer within 30 minutes of reconstitution. Use an NG or gastric tube that is a French size 6 or larger; refill syringe with an equal amount of water, shake, and flush remaining contents through NG or gastric tube.

Storage/Stability

Capsules, tablets: Store at 15°C to 30°C (59°F to 86°F). Protect from light and moisture.

Granules for oral suspension: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Powder for suspension (compounding kits): Refer to manufacturer’s labeling.

OTC capsules: Store at 20°C to 25°C (68°F to 77°F); protect from moisture.

Preparation for Administration: Adult

Granules for oral suspension: For oral administration, empty the contents of the 2.5 mg packet into 5 mL of water (10 mg packet into 15 mL of water); stir. For NG administration, add 5 mL of water into a catheter-tipped syringe, and then add the contents of a 2.5 mg packet (15 mL water for the 10 mg packet); immediately shake syringe. Note: Regardless of the route of administration, the suspension should be left to thicken for 2 to 3 minutes prior to administration.

Preparation for Administration: Pediatric

Oral suspension:

Oral: Mix the contents of the 2.5 mg packet into 5 mL of water or the contents of the 10 mg packet into 15 mL of water; stir; the suspension should be left to thicken for 2 to 3 minutes prior to administration.

Nasogastric tube: Add 5 mL of water into a catheter-tipped syringe, and then add the contents of a 2.5 mg packet or 15 mL water for the 10 mg packet; shake; the suspension should be left to thicken for 2 to 3 minutes prior to administration.

Extemporaneously Prepared

Note: More palatable omeprazole (2 mg/mL) suspensions are commercially available as compounding kits (First-Omeprazole, Omeprazole+Syrspend SF Alka Cherry Kit).

A 2 mg/mL oral omeprazole solution (Simplified Omeprazole Solution) may be made with five omeprazole 20 mg delayed release capsules and 50 mL sodium bicarbonate 8.4%. Empty capsules into beaker. Add sodium bicarbonate solution. Gently stir (about 15 minutes) until a white suspension forms. Transfer to amber-colored syringe or bottle. Stable for 14 days at room temperature or for 30 days refrigerated.

DiGiacinto JL, Olsen KM, Bergman KL, et al, “Stability of Suspension Formulations of Lansoprazole and Omeprazole Stored in Amber-Colored Plastic Oral Syringes,” Ann Pharmacother, 2000, 34(5):600-5. [PubMed 10852086]

Quercia R, Fan C, Liu X, et al, “Stability of Omeprazole in an Extemporaneously Prepared Oral Liquid,” Am J Health Syst Pharm, 1997, 54(16):1833-6. [PubMed 9269520]

Sharma V, “Comparison of 24-hour Intragastric pH Using Four Liquid Formulations of Lansoprazole and Omeprazole,” Am J Health Syst Pharm, 1999, 56(23 Suppl 4):18-21.[PubMed 10597120]

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, nausea, vomiting, diarrhea, or flatulence. Have patient report immediately to prescriber signs of low magnesium (mood changes; muscle pain or weakness; muscle cramps or spasms; seizures; tremors; lack of appetite; severe nausea or vomiting; or an abnormal heartbeat), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of infection, signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), signs of lupus (rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, angina or shortness of breath, or swelling in the arms or legs), severe dizziness, passing out, severe abdominal pain, bone pain, chills, pharyngitis, excessive weight loss, severe loss of strength and energy, signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools), or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  Geriatric Patients: High-Risk Medication:
  International issues:
Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Prilosec capsules, granules for oral suspension: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022056s022lbl.pdf#page=35

Contraindications

Hypersensitivity (eg, anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, urticaria) to omeprazole, other substituted benzimidazole proton pump inhibitors, or any component of the formulation; concomitant use with products that contain rilpivirine

OTC labeling: When used for self-medication (OTC), do not use if trouble or pain when swallowing food; vomiting with blood, or bloody or black stools; heartburn with lightheadedness, dizziness, or sweating; chest pain or shoulder pain with shortness of breath, sweating, pain spreading to arms, neck or shoulders, or lightheadedness; frequent chest pain.

Warnings/Precautions

Concerns related to adverse effects:

• Carcinoma: In long-term (2-year) studies in rats, omeprazole produced a dose-related increase in gastric carcinoid tumors. While available endoscopic evaluations and histologic examinations of biopsy specimens from human stomachs have not detected a risk from short-term exposure to omeprazole, further human data on the effect of sustained hypochlorhydria and hypergastrinemia are needed to rule out the possibility of an increased risk for the development of tumors in humans receiving long-term therapy.

• Clostridioides (formerly Clostridiumdifficile-associated diarrhea (CDAD): Use of proton pump inhibitors (PPIs) may increase risk of CDAD, especially in hospitalized patients; consider CDAD diagnosis in patients with persistent diarrhea that does not improve. Use the lowest dose and shortest duration of PPI therapy appropriate for the condition being treated.

• Cutaneous and systemic lupus erythematosus: Has been reported as new onset or exacerbation of existing autoimmune disease; most cases were cutaneous lupus erythematosus (CLE), most commonly, subacute CLE (occurring within weeks to years after continuous therapy). Systemic lupus erythematosus (SLE) is less common (typically occurs within days to years after initiating treatment) and occurred primarily in young adults up to the elderly. Discontinue therapy if signs or symptoms of CLE or SLE occur and refer to specialist for evaluation; most patients improve 4 to 12 weeks after discontinuation of omeprazole.

• Fractures: Increased incidence of osteoporosis-related bone fractures of the hip, spine, or wrist may occur with proton pump inhibitor (PPI) therapy. Patients on high-dose (multiple daily doses) or long-term (≥1 year) therapy should be monitored. Use the lowest effective dose for the shortest duration of time, use vitamin D and calcium supplementation, and follow appropriate guidelines to reduce risk of fractures in patients at risk.

• Fundic gland polyps: Use of proton pump inhibitors (PPIs) increases risk of fundic gland polyps, especially with long-term use >1 year. May occur without symptoms but nausea, vomiting, or abdominal pain may occur; GI bleeding and/or anemia may occur with ulcerated polyps. Diagnosis of polyps may also increase risk for small intestinal blockage. Use the lowest dose and shortest duration of PPI therapy appropriate for the condition being treated.

• Hypomagnesemia: Reported rarely, usually with prolonged PPI use of ≥3 months (most cases >1 year of therapy). May be symptomatic or asymptomatic; severe cases may cause tetany, seizures, and cardiac arrhythmias. Consider obtaining serum magnesium concentrations prior to beginning long-term therapy, especially if taking concomitant digoxin, diuretics, or other drugs known to cause hypomagnesemia; and periodically thereafter. Hypomagnesemia may be corrected by magnesium supplementation, although discontinuation of omeprazole may be necessary; magnesium levels typically return to normal within 1 week of stopping.

• Interstitial nephritis: Acute interstitial nephritis has been observed in patients taking PPIs; may occur at any time during therapy and is generally due to an idiopathic hypersensitivity reaction. Discontinue if acute interstitial nephritis develops.

• Vitamin B12 deficiency: Prolonged treatment (>3 years) may lead to vitamin B12 malabsorption and subsequent vitamin B12 deficiency. The magnitude of the deficiency is dose-related and the association is stronger in females and those younger in age (<30 years); prevalence is decreased after discontinuation of therapy (Lam, 2013).

Disease-related concerns:

• Gastric malignancy: Relief of symptoms does not preclude the presence of a gastric malignancy.

• Gastrointestinal infection (eg, Salmonella, Campylobacter): Use of PPIs may increase risk of these infections.

• Hepatic impairment: In patients with hepatic impairment (Child-Pugh class A, B, or C) exposure to omeprazole is increased; dosage reduction is recommended.

Concurrent drug therapy issues:

• Clopidogrel: Proton pump inhibitors (PPIs) may diminish the therapeutic effect of clopidogrel, thought to be due to reduced formation of the active metabolite of clopidogrel. The manufacturer of clopidogrel recommends either avoidance of both omeprazole (even when scheduled 12 hours apart) and esomeprazole or use of a PPI with comparatively less effect on the active metabolite of clopidogrel (eg, pantoprazole). In contrast to these warnings, others have recommended the continued use of PPIs, regardless of the degree of inhibition, in patients with a history of GI bleeding or multiple risk factors for GI bleeding who are also receiving clopidogrel since no evidence has established clinically meaningful differences in outcome; however, a clinically significant interaction cannot be excluded in those who are poor metabolizers of clopidogrel (Abraham, 2010; Levine, 2011).

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Asian ethnicity: Bioavailability is increased in patients of Asian descent; dosage reduction is recommended for maintenance healing of erosive esophagitis.

• Elderly: Bioavailability may be increased in the elderly.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP [“Inactive” 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

Other warnings/precautions:

• Appropriate use: Helicobacter pylori eradication: Short-term combination therapy (≤7 days) has been associated with a higher incidence of treatment failure. The American College of Gastroenterology recommends 10 to 14 days of therapy (triple or quadruple) for eradication of H. pylori (Chey 2017).

• Laboratory test interference: Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acid; may cause false-positive results in diagnostic investigations for neuroendocrine tumors. Temporarily stop omeprazole treatment at least 14 days before CgA test; if initial CgA levels are high, repeat test to confirm. Use same commercial laboratory for testing to prevent variable results.

• Self-medication (OTC use): When used for self-medication (OTC), notify health care provider before use if any of the following are present: heartburn for >3 months; frequent wheezing, particularly with heartburn; unexplained weight loss; nausea or vomiting; or stomach pain. Discontinue use and notify health care provider if heartburn continues or worsens; diarrhea occurs; if >14 days of therapy is needed; or if >1 course of therapy is needed every 4 months.

Geriatric Considerations

In clinical trials, the incidence of side effects in the elderly is no different than that of younger adults (≤65 years) despite slight decrease in elimination and increase in bioavailability. Bioavailability may be increased in the elderly (≥65 years of age), however, dosage adjustments are not necessary.

Use has been associated with C. difficile infection, bone loss and fractures, and hypomagnesemia. Refer to Medication Safety Issues for Beers Criteria information.

Pregnancy Considerations

Available data have not shown an increased risk of major birth defects following maternal use of omeprazole during pregnancy.

Recommendations for the treatment of GERD in pregnancy are available. As in nonpregnant patients, lifestyle modifications followed by other medications are the initial treatments (ACG [Katz 2013]; Body 2016; Huerta-Iga 2016; van der Woude 2014). Based on available data, PPIs may be used when clinically indicated (Body 2016; Matok 2012; Pasternak 2010; van der Woude 2014).

Breast-Feeding Considerations

Omeprazole is present in breast milk.

The relative infant dose (RID) of omeprazole is 0.2% to 0.43% when calculated using the highest average breast milk concentration located and compared to an infant therapeutic dose of 0.7 to 1.5 mg/kg/day.

In general, breastfeeding is considered acceptable when the RID is <10% (Anderson 2016; Ito 2000).

The RID of omeprazole was calculated using the highest average milk concentration located (20.03 mcg/L), providing an estimated daily infant dose via breast milk of 0.003 mg/kg/day. This milk concentration was obtained following maternal chronic administration of oral omeprazole 20 mg/day; the peak breast milk concentration occurred 3 hours after the dose (Marshall 1998).

No adverse effects were noted in one infant exposed to omeprazole following maternal administration of oral omeprazole 20 mg/day for 3 months; the authors of this case report noted that the acidic content of a breastfed infants’ stomach may potentially inactivate any ingested omeprazole (Marshall 1998).

According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

1% to 10%:

Central nervous system: Headache (7%), dizziness (2%)

Dermatologic: Skin rash (2%)

Gastrointestinal: Abdominal pain (5%), diarrhea (4%), nausea (4%), flatulence (3%), vomiting (3%), acid regurgitation (2%), constipation (2%)

Neuromuscular & skeletal: Back pain (1%), weakness (1%)

Respiratory: Upper respiratory infection (2%), cough (1%)

<1%, postmarketing, and/or case reports (adverse event occurrence may vary based on formulation): Abdominal swelling, abnormal dreams, aggression, agitation, agranulocytosis, allergic reactions, alopecia, anaphylaxis, anemia, angina pectoris, angioedema, anorexia, anxiety, apathy, arthralgia, atrophic gastritis, blurred vision, bone fracture, bradycardia, bronchospasm, chest pain, cholestatic hepatitis, Clostridioides (formerly Clostridiumdifficile-associated diarrhea (CDAD), colitis (microscopic), confusion, cutaneous lupus erythematosus, depression, dermatitis, diplopia, disturbed sleep, drowsiness, dysgeusia, epistaxis, erythema multiforme, esophageal candidiasis, fatigue, fecal discoloration, fever, gastric carcinoid tumor, gastric polyp (benign), glycosuria, gynecomastia, hallucination, hematuria, hemolytic anemia, hepatic disease (hepatocellular, cholestatic, mixed), hepatic encephalopathy, hepatic failure, hepatic necrosis, hepatitis, hepatocellular hepatitis, hepatotoxicity (idiosyncratic) (Chalasani 2014), hyperhidrosis, hypersensitivity reaction, hypertension, hypocalcemia, hypoglycemia, hypokalemia, hypomagnesemia, hyponatremia, increased gamma glutamyl transferase, increased serum alkaline phosphatase, increased serum ALT, increased serum AST, increased serum bilirubin, increased serum creatinine, insomnia, interstitial nephritis, irritable bowel syndrome, jaundice, leg pain, leukocytosis, leukopenia, malaise, microscopic pyuria, mucosal atrophy (tongue), muscle cramps, myalgia, myasthenia, nervousness, neutropenia, ocular irritation, optic atrophy, optic neuritis, optic neuropathy (anterior ischemic), osteoporosis-related fracture, pain, palpitation, pancreatitis, pancytopenia, paresthesia, peripheral edema, petechiae, photophobia, pneumonia, proteinuria, pruritus, psychiatric disturbance, purpura, renal disease (chronic; Lazarus 2016), skin photosensitivity, sore throat, Stevens-Johnson syndrome, stomatitis, systemic lupus erythematosus, tachycardia, testicular pain, thrombocytopenia, tinnitus, toxic epidermal necrolysis, tremor, urinary frequency, urinary tract infection, urticaria, vertigo, weight gain, xeroderma, xerophthalmia, xerostomia

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of CYP2A6 (minor), CYP2C19 (major), CYP2C9 (minor), CYP2D6 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits CYP2C19 (weak)

Drug Interactions 

Acalabrutinib: Proton Pump Inhibitors may decrease the serum concentration of Acalabrutinib. Risk X: Avoid combination

Amphetamine: Proton Pump Inhibitors may increase the absorption of Amphetamine. Risk C: Monitor therapy

Antihepaciviral Combination Products: May decrease the serum concentration of Omeprazole. Risk C: Monitor therapy

Atazanavir: Proton Pump Inhibitors may decrease the serum concentration of Atazanavir. Management: See full drug interaction monograph for details. Risk D: Consider therapy modification

Bisphosphonate Derivatives: Proton Pump Inhibitors may diminish the therapeutic effect of Bisphosphonate Derivatives. Risk C: Monitor therapy

Bosutinib: Proton Pump Inhibitors may decrease the serum concentration of Bosutinib. Management: Consider alternatives to proton pump inhibitors, such as antacids or H2 receptor antagonists. Administer alternative agents more than 2 hours before or after bosutinib. Risk D: Consider therapy modification

Capecitabine: Proton Pump Inhibitors may diminish the therapeutic effect of Capecitabine. Risk C: Monitor therapy

Cefditoren: Proton Pump Inhibitors may decrease the serum concentration of Cefditoren. Management: If possible, avoid use of cefditoren with proton pump inhibitors (PPIs). Consider alternative methods to minimize/control acid reflux (eg, diet modification) or alternative antimicrobial therapy if use of PPIs can not be avoided. Risk D: Consider therapy modification

Cefpodoxime: Proton Pump Inhibitors may decrease the serum concentration of Cefpodoxime. Risk C: Monitor therapy

Cefuroxime: Proton Pump Inhibitors may decrease the absorption of Cefuroxime. Risk X: Avoid combination

Cilostazol: CYP2C19 Inhibitors may increase the serum concentration of Cilostazol. Management: Consider reducing the cilostazol dose to 50 mg twice daily in patients who are also receiving inhibitors of CYP2C19. Risk D: Consider therapy modification

Citalopram: Omeprazole may increase the serum concentration of Citalopram. Management: Limit citalopram dose to a maximum of 20 mg/day if used with omeprazole. Risk D: Consider therapy modification

CloBAZam: Omeprazole may increase serum concentrations of the active metabolite(s) of CloBAZam. Risk C: Monitor therapy

Clopidogrel: Omeprazole may diminish the antiplatelet effect of Clopidogrel. Omeprazole may decrease serum concentrations of the active metabolite(s) of Clopidogrel. Management: Clopidogrel labeling recommends avoiding concurrent omeprazole due to a possible decrease in clopidogrel effectiveness. Rabeprazole or pantoprazole may be lower-risk alternatives to omeprazole. Risk D: Consider therapy modification

CloZAPine: Omeprazole may decrease the serum concentration of CloZAPine. Omeprazole may increase the serum concentration of CloZAPine. Risk C: Monitor therapy

CycloSPORINE (Systemic): Omeprazole may increase the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy

CYP2C19 Inducers (Moderate): May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). Risk C: Monitor therapy

CYP2C19 Inducers (Strong): May increase the metabolism of CYP2C19 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D: Consider therapy modification

Cysteamine (Systemic): Proton Pump Inhibitors may diminish the therapeutic effect of Cysteamine (Systemic). Risk C: Monitor therapy

Dabrafenib: May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP2C19 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Risk D: Consider therapy modification

Dacomitinib: Proton Pump Inhibitors may decrease the serum concentration of Dacomitinib. Management: Avoid concurrent use of dacomitinib with proton pump inhibitors. Antacids may be used. Histamine H2-receptor antagonists (HR2A) may be used if dacomitinib is given at least 6 hours before or 10 hours after the H2RA. Risk X: Avoid combination

Darunavir: May decrease the serum concentration of Omeprazole. Risk C: Monitor therapy

Dasatinib: Proton Pump Inhibitors may decrease the serum concentration of Dasatinib. Management: Antacids (taken 2 hours before or after dasatinib administration) can be used in place of the proton pump inhibitor if some acid-reducing therapy is needed. Risk X: Avoid combination

Delavirdine: Proton Pump Inhibitors may decrease the serum concentration of Delavirdine. Management: Chronic therapy with proton pump inhibitors (PPIs) should be avoided in patients treated with delavirdine. The clinical significance of short-term PPI therapy with delavirdine is uncertain, but such therapy should be undertaken with caution. Risk X: Avoid combination

Dexmethylphenidate: Proton Pump Inhibitors may increase the absorption of Dexmethylphenidate. Specifically, proton pump inhibitors may interfere with the normal release of drug from the extended-release capsules (Focalin XR brand), which could result in both increased absorption (early) and decreased delayed absorption. Risk C: Monitor therapy

Dextroamphetamine: Proton Pump Inhibitors may increase the absorption of Dextroamphetamine. Specifically, the dextroamphetamine absorption rate from mixed amphetamine salt extended release (XR) capsules may be increased in the first hours after dosing. Risk C: Monitor therapy

Doxycycline: Proton Pump Inhibitors may decrease the bioavailability of Doxycycline. Risk C: Monitor therapy

Enzalutamide: May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). Conversely, concentrations of active metabolites may be increased for those drugs activated by CYP2C19. Management: Concurrent use of enzalutamide with CYP2C19 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP2C19 substrate should be performed with caution and close monitoring. Risk D: Consider therapy modification

Erlotinib: Proton Pump Inhibitors may decrease the serum concentration of Erlotinib. Risk X: Avoid combination

Escitalopram: Omeprazole may increase the serum concentration of Escitalopram. Management: Monitor for increased escitalopram toxicity with concomitant use of omeprazole. Recommendations for management of this interaction found in product labeling may differ by country. Consult appropriate labeling. Risk D: Consider therapy modification

Fluconazole: May increase the serum concentration of Proton Pump Inhibitors. Risk C: Monitor therapy

Fosphenytoin: Omeprazole may increase the serum concentration of Fosphenytoin. Fosphenytoin may decrease the serum concentration of Omeprazole. Risk C: Monitor therapy

Gefitinib: Proton Pump Inhibitors may decrease the serum concentration of Gefitinib. Management: Avoid use of proton pump inhibitors (PPIs) with gefitinib when possible. If required, administer gefitinib 12 hours after administration of the PPI or 12 hours before the next dose of the PPI. Risk D: Consider therapy modification

Indinavir: Proton Pump Inhibitors may decrease the serum concentration of Indinavir. Risk C: Monitor therapy

Iron Salts: Proton Pump Inhibitors may decrease the absorption of Iron Salts. Exceptions: Ferric Carboxymaltose; Ferric Citrate; Ferric Gluconate; Ferric Hydroxide Polymaltose Complex; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Isomaltoside; Iron Sucrose. Risk C: Monitor therapy

Itraconazole: Proton Pump Inhibitors may increase the serum concentration of Itraconazole. Proton Pump Inhibitors may decrease the serum concentration of Itraconazole. Management: Administer Sporanox brand itraconazole at least 2 hours before or 2 hours after administration of any proton pump inhibitors (PPIs). Exposure to Tolsura brand itraconazole may be increased by PPIs; consider itraconazole dose reduction. Risk D: Consider therapy modification

Ketoconazole (Systemic): Proton Pump Inhibitors may decrease the serum concentration of Ketoconazole (Systemic). Ketoconazole (Systemic) may increase the serum concentration of Proton Pump Inhibitors. Risk D: Consider therapy modification

Ledipasvir: Proton Pump Inhibitors may decrease the serum concentration of Ledipasvir. Management: PPI doses equivalent to omeprazole 20 mg or lower may be given with ledipasvir under fasted conditions. Administration with higher doses of PPIs, 2 hours after a PPI, or in combination with food and PPIs may reduce ledipasvir bioavailability. Risk D: Consider therapy modification

Lumacaftor: May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). Risk C: Monitor therapy

Mesalamine: Proton Pump Inhibitors may diminish the therapeutic effect of Mesalamine. Proton pump inhibitor-mediated increases in gastrointestinal pH may cause the premature release of mesalamine from specific sustained-release mesalamine products. Management: Consider avoiding concurrent administration of high-dose proton pump inhibitors (PPIs) with sustained-release mesalamine products. Risk D: Consider therapy modification

Methotrexate: Proton Pump Inhibitors may increase the serum concentration of Methotrexate. Risk C: Monitor therapy

Methylphenidate: Proton Pump Inhibitors may increase the absorption of Methylphenidate. Specifically, proton pump inhibitors may interfere with the normal release of drug from the extended-release capsules (Ritalin LA brand), which could result in both increased absorption (early) and decreased delayed absorption. Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): Proton Pump Inhibitors may decrease the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, the absorption of iron may be decreased. Risk C: Monitor therapy

Mycophenolate: Proton Pump Inhibitors may decrease the serum concentration of Mycophenolate. Specifically, concentrations of the active mycophenolic acid may be reduced. Risk C: Monitor therapy

Nalmefene: Omeprazole may decrease the serum concentration of Nalmefene. Risk C: Monitor therapy

Nelfinavir: Proton Pump Inhibitors may decrease serum concentrations of the active metabolite(s) of Nelfinavir. Proton Pump Inhibitors may decrease the serum concentration of Nelfinavir. Risk X: Avoid combination

Neratinib: Proton Pump Inhibitors may decrease the serum concentration of Neratinib. Specifically, proton pump inhibitors may reduce neratinib absorption. Risk X: Avoid combination

Nilotinib: Proton Pump Inhibitors may decrease the serum concentration of Nilotinib. Management: Avoid this combination when possible since separation of doses is not likely to be an adequate method of minimizing the interaction. Risk D: Consider therapy modification

PAZOPanib: Proton Pump Inhibitors may decrease the serum concentration of PAZOPanib. Risk X: Avoid combination

Phenytoin: May decrease the serum concentration of Omeprazole. Omeprazole may increase the serum concentration of Phenytoin. Risk C: Monitor therapy

Posaconazole: Proton Pump Inhibitors may decrease the serum concentration of Posaconazole. Risk D: Consider therapy modification

Raltegravir: Proton Pump Inhibitors may increase the serum concentration of Raltegravir. Risk C: Monitor therapy

RifAMPin: May decrease the serum concentration of Omeprazole. Risk X: Avoid combination

Rilpivirine: Proton Pump Inhibitors may decrease the serum concentration of Rilpivirine. Risk X: Avoid combination

Riociguat: Proton Pump Inhibitors may decrease the serum concentration of Riociguat. Risk C: Monitor therapy

Risedronate: Proton Pump Inhibitors may diminish the therapeutic effect of Risedronate. Proton Pump Inhibitors may increase the serum concentration of Risedronate. This applies specifically to use of delayed-release risedronate. Risk X: Avoid combination

Saquinavir: Proton Pump Inhibitors may increase the serum concentration of Saquinavir. Risk C: Monitor therapy

Secretin: Proton Pump Inhibitors may diminish the diagnostic effect of Secretin. Specifically, use of PPIs may cause a hyperresponse in gastrin secretion in response to secretin stimulation testing, falsely suggesting gastrinoma. Management: Avoid concomitant use of proton pump inhibitors (PPIs) and secretin, and discontinue PPIs several weeks prior to secretin administration, with the duration of separation determined by the specific PPI. See full monograph for details. Risk D: Consider therapy modification

St John’s Wort: May decrease the serum concentration of Omeprazole. Risk X: Avoid combination

Tacrolimus (Systemic): Proton Pump Inhibitors may increase the serum concentration of Tacrolimus (Systemic). Management: Tacrolimus dose adjustment may be required. Rabeprazole, pantoprazole, or selected H2-receptor antagonists (i.e., ranitidine or famotidine) may be less likely to interact. Genetic testing may predict patients at highest risk. Risk D: Consider therapy modification

Tipranavir: May decrease the serum concentration of Proton Pump Inhibitors. These data are derived from studies with Ritonavir-boosted Tipranavir. Risk C: Monitor therapy

Velpatasvir: Proton Pump Inhibitors may decrease the serum concentration of Velpatasvir. Risk X: Avoid combination

Vitamin K Antagonists (eg, warfarin): Omeprazole may increase the serum concentration of Vitamin K Antagonists. Risk C: Monitor therapy

Voriconazole: May increase the serum concentration of Proton Pump Inhibitors. Proton Pump Inhibitors may increase the serum concentration of Voriconazole. Management: In patients receiving omeprazole 40 mg/day or greater, reduce omeprazole dose by half when initiating voriconazole. Risk C: Monitor therapy

Food Interactions

Prolonged treatment (≥2 years) may lead to malabsorption of dietary vitamin B12 and subsequent vitamin B12 deficiency (Lam, 2013).

Test Interactions

Omeprazole may falsely elevate serum chromogranin A (CgA) levels. The increased CgA level may cause false-positive results in the diagnosis of a neuroendocrine tumor. Temporarily stop omeprazole ≥14 days prior to assessing CgA level; repeat level if initially elevated; use the same laboratory for all testing of CgA levels.

Genes of Interest
Monitoring Parameters

Susceptibility testing is recommended in patients who fail H. pylori-eradication regimen; magnesium levels (prior to initiation of therapy and periodically thereafter).

Advanced Practitioners Physical Assessment/Monitoring

For patients at risk of osteoporosis-related fractures, optimize preventive measures and limit high-dose, prolonged therapy if possible.

Nursing Physical Assessment/Monitoring

Optimize prevention of fractures in patients with osteoporosis.

Dosage Forms Considerations

First-Omeprazole and Omeprazole+Syrspend SF Alka oral suspensions are compounding kits. Refer to manufacturer’s labeling for compounding instructions.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule Delayed Release, Oral:

PriLOSEC: 10 mg [DSC], 20 mg [DSC], 40 mg [DSC]

Generic: 10 mg, 20 mg, 40 mg

Capsule Delayed Release, Oral, as magnesium [strength expressed as base]:

Generic: 20 mg

Packet, Oral, as magnesium [strength expressed as base]:

PriLOSEC: 2.5 mg (30 ea); 10 mg (30 ea)

Tablet Delayed Release, Oral:

Generic: 20 mg, 20 mg

Tablet Delayed Release, Oral, as magnesium [strength expressed as base]:

PriLOSEC OTC: 20 mg

PriLOSEC OTC: 20 mg [contains fd&c blue #2 aluminum lake, fd&c red #40 aluminum lake, saccharin sodium; wild berry flavor]

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule Delayed Release, Oral:

Losec: 20 mg

Generic: 10 mg, 20 mg, 40 mg

Tablet Delayed Release, Oral:

Losec: 10 mg

Generic: 10 mg

Tablet Delayed Release, Oral, as magnesium [strength expressed as base]:

Losec: 20 mg

Generic: 20 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • A02BC01
Generic Available (US)

May be product dependent

Pricing: US

Capsule, delayed release (Omeprazole Magnesium Oral)

20.6 (20 Base) mg (per each): $0.59 – $0.77

Capsule, delayed release (Omeprazole Oral)

10 mg (per each): $3.01 – $3.99

20 mg (per each): $2.92 – $4.45

40 mg (per each): $6.69 – $7.40

Pack (PriLOSEC Oral)

2.5 mg (per each): $12.57

10 mg (per each): $12.57

Tablet, EC (Omeprazole Oral)

20 mg (per each): $0.66 – $8.79

Tablet, EC (PriLOSEC OTC Oral)

20 mg (per each): $0.72

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Proton pump inhibitor; suppresses gastric basal and stimulated acid secretion by inhibiting the parietal cell H+/K+ ATP pump

Pharmacodynamics/Kinetics

Note: Half-life and AUC were significantly reduced for omeprazole suspension when compared with an equivalent dose via the commercially available capsule in 7 adults (Song 2001).

Onset of action: Antisecretory: ~1 hour

Peak effect: Within 2 hours

Duration: Up to 72 hours; 50% of maximum effect at 24 hours; after stopping treatment, secretory activity gradually returns over 3 to 5 days

Maximum secretory inhibition: 4 days

Absorption: Rapid

Protein binding: ~95%

Metabolism: Hepatic via CYP2C19 primarily and (to a lesser extent) via 3A4 to hydroxy, desmethyl, and sulfone metabolites (all inactive); saturable first-pass effect

Bioavailability: Oral: ~30% to 40%; Hepatic dysfunction: ~100%; Asians: AUC increased up to fourfold compared to Caucasians

Half-life elimination: 0.5 to 1 hour; hepatic impairment: ~3 hours

Time to peak, plasma: 0.5 to 3.5 hours

Excretion: Urine (~77% as metabolites, very small amount as unchanged drug); feces

Clearance: 500-600 mL/minute; chronic hepatic disease: 70 mL/minute

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: There is slight increase in bioavailability in patients whose CrCl ranged between 10 and 62 mL/minute/1.73 m2.

Hepatic function impairment: In patients with hepatic impairment (Child-Pugh class A, B, or C), bioavailability is increased ~100%, plasma half-life is increased, and plasma clearance is decreased.

Geriatric: The elimination rate is decreased; bioavailability is increased.

Race: AUC is increased ~4-fold in Asian patients.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Taste perversion, dry mouth, esophageal candidiasis, and mucosal atrophy (tongue).

Effects on Bleeding

No information available to require special precautions

Index Terms

Omeprazole Magnesium

FDA Approval Date
September 14, 1989
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Hawkey CJ, Karrasch JA, Szczepañski L, et al; OMNIUM Study Group. Omeprazole compared with misoprostol for ulcers associated with nonsteroidal antiinflammatory drugs. N Engl J Med. 1998;338(11):727-734. doi: 10.1056/NEJM199803123381105.[PubMed 9494149]

Hershcovici T, Fass R. An algorithm for diagnosis and treatment of refractory GERD. Best Pract Res Clin Gastroenterol. 2010;24(6):923-936.[PubMed 21126704]

Huerta-Iga F, Bielsa-Fernández MV, Remes-Troche JM, et al. Diagnosis and treatment of gastroesophageal reflux disease: recommendations of the Asociación Mexicana de Gastroenterología. Rev Gastroenterol Mex. 2016;81(4):208-222.[PubMed 27595382]

“Inactive” ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278.[PubMed 9024461]

Internal Clinical Guidelines Team (UK). Dyspepsia and gastro-oesophageal reflux disease: investigation and management of dyspepsia, symptoms suggestive of gastro-oesophageal reflux disease, or both. National Institute for Health and Care Excellence: Clinical Guidelines. London: National Institute for Health and Care Excellence (UK); 2014.[PubMed 25340236]

Ito S. Drug therapy for breast-feeding women. N Engl J Med. 2000;343(2):118-126.[PubMed 10891521]

Kahrilas PJ. Medical management of gastroesophageal reflux disease in adult. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed December 21, 2017.[PubMed 10891521]

Kahrilas PJ, Shaheen NJ, Vaezi MF, et al, “American Gastroenterological Association Medical Position Statement on the Management of Gastroesophageal Reflux Disease,” Gastroenterology, 2008, 135(4):1383-91.[PubMed 18789939]

Kahrilas PJ, Shaheen NJ, Vaezi MF; American Gastroenterological Association Institute; Clinical Practice and Quality Management Committee. American Gastroenterological Association Institute technical review on the management of gastroesophageal reflux disease. Gastroenterology. 2008;135(4):1392-1413, 1413.e1-e5.[PubMed 18801365]

Källén BA, “Use of Omeprazole During Pregnancy-No Hazard Demonstrated in 955 Infants Exposed During Pregnancy,” Eur J Obstet Gynecol Reprod Biol, 2001, 96(1):63-8.[PubMed 11311763]

Kane DL, “Administration of Omeprazole (Prilosec®) in the Atypical Patient,” Int J Pharm Compounding, 1997, 1(1):13.

Kato S, Ebina K, Fujii K, et al, “Effect of Omeprazole in the Treatment of Refractory Acid-Related Diseases in Childhood: Endoscopic Healing and Twenty-Four Hour Intragastric Acidity,” J Pediatr, 1996, 128(3):415-21.[PubMed 8774516]

Katz PO, Gerson LB, and Vela MF, “Guidelines for the Diagnosis and Management of Gastroesophageal Reflux Disease,” Am J Gastroenterol, 2013, 108(3):308-28.[PubMed 23419381]

Kim J, Blackett JW, Jodorkovsky D. Strategies for effective discontinuation of proton pump inhibitors. Curr Gastroenterol Rep. 2018;20(6):27. doi: 10.1007/s11894-018-0632-y.[PubMed 29767318]

Kraus A and Flores-Suarez LF, “Acute Gout Associated With Omeprazole,” Lancet, 1995, 345(8947):461-2.[PubMed 7853986]

Lalkin A, Loebstein R, Addis A, et al, “The Safety of Omeprazole During Pregnancy: A Multicenter Prospective Controlled Study,” Am J Obstet Gynecol, 1998, 179(3 Pt 1):727-30.[PubMed 9757979]

Lam JR, Schneider JL, Zhao W, Corley DA. Proton pump inhibitor and histamine 2 receptor antagonist use and vitamin B12 deficiency. JAMA. 2013;310(22):2435-2422.[PubMed 24327038]

Lanza FL, Chan FK, Quigley EM; Practice Parameters Committee of the American College of Gastroenterology. Guidelines for prevention of NSAID-related ulcer complications. Am J Gastroenterol. 2009;104(3):728-738. doi: 10.1038/ajg.2009.115.[PubMed 19240698]

Larner AJ and Lendrum R, “Oesophageal Candidiasis After Omeprazole Therapy,” Gut, 1992, 33(6):860-1.[PubMed 1624174]

Lau JY, Sung JJ, Lee KK, et al, “Effect of Intravenous Omeprazole on Recurrent Bleeding After Endoscopic Treatment of Bleeding Peptic Ulcers,” N Engl J Med, 2000, 343(5):310-6.[PubMed 10922420]

Lazarus B, Chen Y, Wilson FP, et al. Proton pump inhibitor use and the risk of chronic kidney disease. JAMA Intern Med. 2016:238-246.[PubMed 26752337]

Levine GN, Bates ER, Blankenship JC, et al, “2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions,” Circulation, 2011, 124(23):e574-651.[PubMed 22064601]

Levy MJ, Seelig CB, Robinson NJ, et al, “Comparison of Omeprazole and Ranitidine for Stress Ulcer Prophylaxis,” Dig Dis Sci, 1997, 42(6):1255-59.[PubMed 9201091]

Lindquist M and Edwards IR, “Endocrine Adverse Effects of Omeprazole,” BMJ, 1992, 305(6851):451-2.[PubMed 1392958]

Losec (omeprazole) [product monograph]. Mississauga, Ontario, Canada: AstraZenecaCanada Inc; November 2017.

Marshall JK, Thompson AB, and Armstrong D, “Omeprazole for Refractory Gastroesophageal Reflux Disease During Pregnancy and Lactation,” Can J Gastroenterol, 1998, 12(3):225-7.[PubMed 9582548]

Matok I, Levy A, Wiznitzer A, et al, “The Safety of Fetal Exposure to Proton-Pump Inhibitors During Pregnancy,” Dig Dis Sci, 2012, 57(3):699-705.[PubMed 22038541]

Meineche-Schmidt V. Empiric treatment with high and standard dose of omeprazole in general practice: two-week randomized placebo-controlled trial and 12-month follow-up of health-care consumption. Am J Gastroenterol. 2004;99(6):1050-1058.[PubMed 15180724]

Moayyedi PM, Lacy BE, Andrews CN, Enns RA, Howden CW, Vakil N. ACG and CAG clinical guideline: management of dyspepsia. Am J Gastroenterol. 2017;112(7):988-1013. doi: 10.1038/ajg.2017.154.[PubMed 28631728]

Natsch S, Vinks MH, Voogt AK, et al, “Anaphylactic Reactions to Proton-Pump Inhibitors,” Ann Pharmacother, 2000, 34(4):474-6.[PubMed 10772433]

Omeprazole delayed-release capsules [prescribing information]. Mahwah, NJ: Glenmark Pharmaceuticals Inc; February 2018.

Omeprazole Magnesium [prescribing information]. Brooklyn, NY: Geri-Care Pharmaceuticals Corp; received February 2016.

Ottervanger JP, Stricker BH, Kappelle JW, et al, “Omeprazole-Associated Agranulocytosis,” Eur J Haematol, 1995, 54(4):279-80.[PubMed 7789474]

Paoluzi P, Iacopini F, Crispino P, et al, “2-Week Triple Therapy for Helicobacter pylori Infection is Better Than 1-Week in Clinical Practice: A Large Prospective Single-Center Randomized Study,” Helicobacter, 2006, 11(6):562-8.[PubMed 17083378]

Pasternak B and Hviid A, “Use of Proton-Pump Inhibitors in Early Pregnancy and the Risk of Birth Defects,” N Engl J Med, 2010, 363(22):2114-23.[PubMed 21105793]

Phillips JO, Metzler MH, Palmieri MT, et al, “A Prospective Study of Simplified Omeprazole Suspension for the Prophylaxis of Stress-Related Mucosal Damage,” Crit Care Med, 1996, 24(11):1793-800.[PubMed 8917027]

Pinto-Sanchez MI, Yuan Y, Bercik P, Moayyedi P. Proton pump inhibitors for functional dyspepsia [published update appears in Cochrane Database Syst Rev. 2017;11:CD011194]. Cochrane Database Syst Rev. 2017;3:CD011194. doi: 10.1002/14651858.CD011194.pub2.[PubMed 28271513]

Prilosec (omeprazole) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals; August 2018.

Prilosec OTC (omeprazole) [prescribing information]. Cincinnati, OH: P & G Health; received April 2018.

Quercia R, Fan C, Liu X, et al, “Stability of Omeprazole in an Extemporaneously Prepared Oral Liquid,” Am J Health Syst Pharm, 1997, 54(16):1833-6.[PubMed 9269520]

Ramakrishnan A, Katz PO. Pharmacologic management of gastroesophageal reflux disease. Curr Treat Options Gastroenterol. 2002;5(4):301-310.[PubMed 12095478]

Regula J, Butruk E, Dekkers CP, et al. Prevention of NSAID-associated gastrointestinal lesions: a comparison study pantoprazole versus omeprazole. Am J Gastroenterol. 2006;101(8):1747-1755. doi: 10.1111/j.1572-0241.2006.00686.x.[PubMed 16817839]

Rhodes A, Evans LE, Alhazzani W, et al. Surviving Sepsis Campaign: international guidelines for management of sepsis and septic shock: 2016. Intensive Care Med. 2017;43(3):304-377. doi: 10.1007/s00134-017-4683-6.[PubMed 28101605]

Richter JE, Kahrilas PJ, Johanson J, et al; Esomeprazole Study Investigators. Efficacy and safety of esomeprazole compared with omeprazole in GERD patients with erosive esophagitis: a randomized controlled trial. Am J Gastroenterol. 2001;96(3):656-665.[PubMed 11280530]

Sharma V, “Comparison of 24-hour Intragastric pH Using Four Liquid Formulations of Lansoprazole and Omeprazole,” Am J Health Syst Pharm, 1999, 56(23 Suppl 4):18-21.[PubMed 10597120]

Soll AH, Weinstein WM, Kurata J, et al, “Nonsteroidal Anti-inflammatory Drugs and Peptic Ulcer Disease,” Ann Intern Med, 1991, 114(4):307-19.[PubMed 1987878]

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Veldhuyzen van Zanten SJ, Chiba N, Armstrong D, et al. A randomized trial comparing omeprazole, ranitidine, cisapride, or placebo in helicobacter pylori negative, primary care patients with dyspepsia: the CADET-HN Study. Am J Gastroenterol. 2005;100(7):1477-1488.[PubMed 15984968]

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Woods DJ and McClintock AD, “Omeprazole Administration,” Ann Pharmacother, 1993, 27(5):651.[PubMed 8347919]

Yeomans ND, Tulassay Z, Juhász L, et al; ASTRONAUT Study Group. A comparison of omeprazole with ranitidine for ulcers associated with nonsteroidal antiinflammatory drugs. N Engl J Med. 1998;338(11):719-726. doi: 10.1056/NEJM199803123381104.[PubMed 9494148]

Brand Names: International

Acidcare (BE); Acifre (PH); Acimax (AU); Aleprozil (MX); Amelxess (EG); Antra (AT, IT); Arapride (ES); Aulcer (ES); Azoran (MX); Benzol (MT); Crismel (HU); Desec (TH); Domer (MX); Dudencer (HK); Duogas (TH); Epirazole (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE); Eupept (BR); Ezrazole (PH); Gasec (BB, BM, BS, BZ, EC, GY, HK, JM, MY, SR, TT, UA); Gasec Gastrocaps (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM); Gastec (AR); Gastop (PE); Gastracid (DE); Gastrofer (ID); Getzone (VN); Healor (BD); Helizol (EC); Hyposec (AE, CY, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE); Inhibitron (CR, DO, GT, HN, MX, NI, PA, SV); Inhipump (ID); Lensor (LU); Locid (ET); Logastric (BE); Lokev (ID); Lokit (ET); Lomac (IN); Lomex (PY); Lopraz (IE); Losamel (IE); Losec (AE, AR, AT, AU, BB, BE, BF, BH, BJ, BM, BR, BS, BZ, CI, CN, CY, CZ, DK, EE, EG, ES, ET, FI, GB, GH, GM, GN, GR, GY, HK, HU, IE, IL, IQ, IR, IS, IT, JM, JO, KE, KW, LB, LR, LU, LY, MA, ML, MR, MT, MU, MW, MX, MY, NE, NG, NL, NZ, OM, PH, PK, PL, PT, PY, QA, RO, RU, SA, SC, SD, SE, SL, SN, SR, SY, TN, TR, TW, TZ, UG, UY, VE, VN, YE, ZM); Losec MUPS (CO, EG, MY, PH); Loseprazol (SI); Luodan (CN); Madiprazole (TH); Maxor (AU); Medoprazole (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MT, MU, MW, MY, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM); Mepha Gasec (CR, DO, GT, HN, NI, PA, SV); Mepracid (PH); Meprazol (AU); Minisec (BH); Miracid (TH); Mopral (FR, MX); Nocid (HK, TH); Ocid (ET, IN, LK, SG); Ogal (CO, PE); Olexin (MX); Olit (SG); Om (BD); Omed (BF, BJ, CH, CI, ET, GH, GM, GN, ID, IN, KE, KR, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM); Omedar (AE, CY, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE); Omelon (MY, TW); Omep (BD, HK, UA); OMEP (DE); Omepra (IL); Omepradex (IL); Omepradex-Z (IL); Omepral (AU, JP); Omeprazon (JP); Omepril (EC); Omeq (KR); Omesec (HK, MY, SG); Omex (CO); Omez (VN); Omezol (AE, CY, IN, IQ, IR, JO, KW, LB, LY, NZ, OM, SA, SY, YE); Omezole (HK, SG, TW); Omezzol (EC); Omicap (ZW); Omilock (MY); Omisec (AE, CY, IQ, IR, JO, KW, LB, LY, OM, SA, SY, YE); Omiz (BH, QA); Omizac (IN, ZW); Omizec (HK); OMP (KR); Ompranyt (MT); Omprazole (KR); OMZ (ID); Onic (ID); Opal (PE); Opel (PH); Oprax (PE); Oprazole (AE, BH, JO, KW, LB, QA, SA); Orazole (CR, DO, GT, HN, NI, PA, SV); Ortanol (HR); Ozmep (AU); Parizac (ES); Penrazole (SG); Peptaz (LK); Peptizole (TH); Prazidec (MX); Prazole (TH); Prenome (BE); Probitor (AU, BG, MY, SG, ZW); Proceptin (SG); Promezol (ID); Protonix (PH); Pumpitor (ID, LK, SG); Pumpitor DI (ID); Qrazol (KR); Ramezol (KR); Reglacid (BE); Result (KR); Risek (AE, BH, ET, JO, KW, LB, MY, PH, QA, SA); Romep (IE); Sedacid (BE); Siozole (IN); Stomacer (ID); Stomec (TH); Suifac (MX); Trisec (LK); Ulceral (QA); Ulcozol (EC, PE); Ulnor (DE); Ulpraz (ID); Ulsen (MX); Ultop (HR, UA); Ulzec (ZA); Ulzol (ID); Vescomecid (TH); Viprazo (PH); Vulcasid (MX); Wonmp (KR); Xeldrin (BD); Xoprin (PE); Zatrol (CL); Zefxon (MY, TH); Zenpro (MY, SG); Zenprol (HK); Zimor (MY, SG); Ziom (LK); Zpmacid (ZW)

Omeprazole (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(oh MEP ra zole)

Brand Names: US

PriLOSEC; PriLOSEC OTC [OTC]

Brand Names: Canada

Losec; Olex

What is this drug used for?
  • It is used to treat or prevent GI (gastrointestinal) ulcers caused by infection.
  • It is used to treat gastroesophageal reflux disease (GERD; acid reflux).
  • It is used to treat heartburn.
  • It is used to treat syndromes caused by lots of stomach acid.
  • It is used to treat or prevent ulcers of the swallowing tube (esophagus).
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to omeprazole or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are taking any of these drugs: Atazanavir, clopidogrel, nelfinavir, rifampin, rilpivirine, or St. John’s wort.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
  • Call your doctor if you have throat pain, chest pain, very bad belly pain, trouble swallowing, or signs of a bleeding ulcer like black, tarry, or bloody stools, throwing up blood, or throw up that looks like coffee grounds. These may be signs of a worse health problem.
  • This drug may raise the chance of hip, spine, and wrist fractures in people with weak bones (osteoporosis). The chance may be higher if you take this drug in high doses or for longer than a year, or if you are older than 50 years old. Talk with your doctor.
  • Use care if you have risks for soft, brittle bones (osteoporosis). Some of these risks include drinking alcohol, smoking, taking steroids, taking drugs to treat seizures, or having family members with osteoporosis. Talk with your doctor about your risks of osteoporosis.
  • Low magnesium levels have rarely happened in people taking drugs like this one for at least 3 months. Most of the time, this has happened after 1 year of care. You will need to have your blood work checked if you will be taking this drug for a long time or if you take certain other drugs like digoxin or water pills. Talk with your doctor.
  • Rarely, long-term treatment (for instance longer than 3 years) with drugs like this one has caused low vitamin B-12 levels. Call your doctor right away if you have signs of low vitamin B-12 levels like shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, tiredness, mood changes, or numbness or tingling in the arms or legs.
  • Do not take this drug for longer than you were told by your doctor.
  • This drug may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this drug with your other drugs.
  • Lupus has happened with this drug, as well as lupus that has gotten worse in people who already have it. Tell your doctor if you have lupus. Call your doctor right away if you have signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
  • Very bad pancreas, liver, and white blood cell problems have happened in people who were taking this drug. Rarely, these have been fatal. Talk with the doctor if you have questions.
  • If you are of Asian descent, use this drug with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low magnesium levels like mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, not hungry, very bad upset stomach or throwing up, or a heartbeat that does not feel normal.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Very bad dizziness or passing out.
  • Very bad belly pain.
  • Bone pain.
  • Fever or chills.
  • Sore throat.
  • A big weight loss.
  • Feeling very tired or weak.
  • This drug may raise the chance of a severe form of diarrhea called C diff-associated diarrhea (CDAD). Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat diarrhea without first checking with your doctor.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Headache.
  • Belly pain.
  • Upset stomach or throwing up.
  • Diarrhea.
  • Gas.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Take this drug before meals.
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • Tablets and capsules:
  • Swallow whole. Do not chew or crush.
  • Capsules:
  • You may sprinkle contents of capsule on applesauce. Do not chew. Swallow right away and follow with cool water.
  • After mixing, take your dose right away. Do not store for future use.
  • Powder for suspension:
  • Mix the 2.5 mg packet contents with 1 teaspoon (5 mL) of water or the 10 mg packet contents with 1 tablespoon (15 mL) of water. Let sit for 2 to 3 minutes, stir, and drink. Rinse cup with more water and drink.
  • If the dose is more than 1 packet, follow how to mix as you were told by the doctor or pharmacist.
  • Take your dose within 30 minutes after mixing. Throw away any part not used within 30 minutes of mixing.
  • Those who have feeding tubes may use this drug. Use as you have been told. Flush the feeding tube after this drug is given.
  • Liquid (suspension):
  • Shake well before use.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Liquid (suspension):
  • Store in a refrigerator. Do not freeze.
  • Protect from light.
  • Check with your pharmacist about when you need to throw away this drug.
  • All other products:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Tablets and capsules:
  • Protect from light.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Omeprazole (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(oh MEP ra zole)

Brand Names: US

PriLOSEC; PriLOSEC OTC [OTC]

Brand Names: Canada

Losec; Olex

What is this drug used for?
  • It is used to treat or prevent GI (gastrointestinal) ulcers caused by infection.
  • It is used to treat gastroesophageal reflux disease (GERD; acid reflux).
  • It is used to treat heartburn.
  • It is used to treat syndromes caused by lots of stomach acid.
  • It is used to treat or prevent ulcers of the swallowing tube (esophagus).
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child is taking any of these drugs: Atazanavir, clopidogrel, nelfinavir, rifampin, rilpivirine, or St. John’s wort.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
  • Call the doctor if your child has throat pain, chest pain, very bad belly pain, trouble swallowing, or signs of a bleeding ulcer like black, tarry, or bloody stools, throwing up blood, or throw up that looks like coffee grounds. These may be signs of a worse health problem.
  • This drug may raise the chance of hip, spine, and wrist fractures in people with weak bones (osteoporosis). The chance may be higher if this drug is taken in high doses or for longer than a year. Talk with the doctor.
  • Use care if your child has risks for soft, brittle bones (osteoporosis). Some of these risks include drinking alcohol, smoking, taking steroids, taking drugs to treat seizures, or having family members with osteoporosis. Talk with your child’s doctor about your child’s risks of osteoporosis.
  • Low magnesium levels have rarely happened in people taking drugs like this one for at least 3 months. Most of the time, this has happened after 1 year of care. Your child will need to have their blood work checked if they will be taking this drug for a long time or if they take certain other drugs like digoxin or water pills. Talk with the doctor.
  • Rarely, long-term treatment (for instance longer than 3 years) with drugs like this one has caused low vitamin B-12 levels. Call your child’s doctor right away if your child has signs of low vitamin B-12 levels like shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, tiredness, mood changes, or numbness or tingling in the arms or legs.
  • Do not have your child use longer than you have been told by your child’s doctor.
  • This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
  • Lupus has happened with this drug, as well as lupus that has gotten worse in people who already have it. Tell your child’s doctor if your child has lupus. Call your child’s doctor right away if your child has signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
  • Very bad pancreas, liver, and white blood cell problems have happened in people who were taking this drug. Rarely, these have been fatal. Talk with the doctor if you have questions.
  • If your child is of Asian descent, use this drug with care. Your child could have more side effects.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low magnesium levels like mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, not hungry, very bad upset stomach or throwing up, or a heartbeat that does not feel normal.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Very bad dizziness or passing out.
  • Very bad belly pain.
  • Bone pain.
  • Fever or chills.
  • Sore throat.
  • A big weight loss.
  • Feeling very tired or weak.
  • This drug may raise the chance of a severe form of diarrhea called C diff-associated diarrhea (CDAD). Call your child’s doctor right away if your child has stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat diarrhea without first checking with your child’s doctor.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Headache.
  • Belly pain.
  • Upset stomach or throwing up.
  • Diarrhea.
  • Gas.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Give before meals.
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • Tablets and capsules:
  • Have your child swallow whole. Do not let your child chew or crush.
  • Capsules:
  • You may sprinkle contents of capsule on applesauce. Have your child swallow right away without chewing and follow with water or juice.
  • Give the mixture right away. Do not store for use at a later time.
  • Powder for suspension:
  • Mix the 2.5 mg packet contents with 1 teaspoon (5 mL) of water or the 10 mg packet contents with 1 tablespoon (15 mL) of water. Let sit for 2 to 3 minutes, stir, and have your child drink. Rinse cup with more water and have your child drink.
  • If the dose is more than 1 packet, follow how to mix as you were told by the doctor or pharmacist.
  • Give your child the dose within 30 minutes after mixing. Throw away any part not used within 30 minutes of mixing.
  • Those who have feeding tubes may use this drug. Use as you have been told. Flush the feeding tube after this drug is given.
  • Liquid (suspension):
  • Shake well before use.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Liquid (suspension):
  • Store in a refrigerator. Do not freeze.
  • Protect from light.
  • Check with your pharmacist about when you need to throw away this drug.
  • All other products:
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Tablets and capsules:
  • Protect from light.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.